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Michigan Devicemaker Hit for Complaint Procedures

September 12, 2019

The FDA hit Sturgis, Michigan orthotic devicemaker Freeman Manufacturing with a Form 483 over its complaint handling procedure, which did not establish a process for investigating complaints.

The agency noted a complaint during its March 6-7 inspection involving “material separations from plastic” that contained no details of an investigation.

Another customer complained that a product it received was “too small,” but the customer’s name, address and phone number were not taken down in the complaint, and no investigation details or replies were documented.

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